Ophthalmic Advisory Committee To Consider Two New Fields For Drug Therapy
This article was originally published in The Pink Sheet Daily
Genentech's Lucentis (ranibizumab) for diabetic macular edema and ThromboGenics's Jetrea (ocriplasmin intravitreal injection) for symptomatic vitreomacular adhesions would both be the first pharmacologic intervention for those indications, replacing surgical standards of care.
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In a vote, the panel expressed little confidence in the adequacy of the available evidence on whether there are clinically meaningful differences in outcomes among the anti-VEGF agents.
Novartis' ophthalmic unit Alcon will collaborate with Belgium's ThromboGenics on the marketing and future development of the vitreomacular adhesion therapy, ocriplasmin.
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.